Quality Specialist - Pharmacovigilance (Remote)

Nesco Resource; Jersey City (NJ); Remote; USD 70,000 - 100,000; Full time

Job summary

An established industry player is seeking a detail-oriented professional to join their team in a remote capacity. This role focuses on ensuring compliance in Pharmacovigilance reporting, requiring a strong analytical mindset and a solid understanding of PV principles. You will be responsible for reviewing safety reports and assisting in compliance monitoring processes, contributing to the quality of critical safety data. This is a unique opportunity to work in a dynamic environment where your expertise will directly impact patient safety and regulatory adherence. If you have a passion for quality and compliance in the life sciences, this position is perfect for you.

Qualifications

• 4-5 years of experience in Pharmacovigilance investigations or deviation management.
• Strong analytical skills and knowledge of PV regulations.

Responsibilities

• Review individual case safety report compliance monitoring outputs.
• Assist in developing processes for monitoring compliance.

Skills

Analytical Skills

Quality Focus

Pharmacovigilance Knowledge

Compliance Monitoring

Education

Bachelor's degree in life science

Master's degree in life science

Tools

Office 365

ARGUS Safety Database

Job description

Under the direction and oversight of the PV Quality and Compliance Associate Director, this role will:

1. Perform reviews of individual case safety report compliance monitoring outputs to ensure high quality and compliant reporting in accordance with PV regulations and business partner agreements.
2. Assist with the development and implementation of processes used to monitor the compliance of individual case safety reports.
3. Participate in compliance monitoring special projects as needed to ensure data quality.

Education and Experience:

1. Bachelor's degree/Master's degree in life science with minimum 4-5 years of relevant experience within investigation, deviation in the Pharmacovigilance (PV) space.
2. Strong analytical skills and quality focus.
3. Knowledge of Pharmacovigilance principles, systems, and requirements in addition to Pharmacovigilance regulations.
4. Experience with Pharmacovigilance investigations or deviation management.

Software expertise:

1. Office 365 applications.
2. Safety database (ARGUS is preferable).
3. Will consider someone with similar software experience to ARGUS.

Note:

1. 3 months assignment with possibility of extension.
2. 100% remote role.
3. Should have their own laptop or desktop to perform the work.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.